Obesity drug linked to mental disorders
The Irish Medicines Board (IMB) confirmed last night that the prescription-only drug, Acomplia, would no longer be available on the Irish market.
The IMB’s decision is in line with the European Medicines Agency (EMEA) recommendation that the licence for the drug, marketed by Sanofi-Aventis, be suspended across the EU.
The move followed an assessment of the most recent data of the drug that confirmed there was an increased risk of psychiatric disorders for patients.
The IMB was involved in the decision taken at European level that the benefits of Acomplia no longer outweigh the risks.
According to the IMB, there is a “relatively small” number of patients taking the drug.
IMB’s director of human medicines, Dr Joan Gilvarry, said patients taking Acomplia should stop their treatment and visit their GP.
“No further prescriptions for Acomplia should be prescribed or dispensed by doctors and pharmacists,” she stressed.
Warnings about the side effects were included in Acomplia’s product information since it was first licensed and were updated and strengthened over time.
Sanofi-Aventis said it would continue to research the therapeutic benefits of the drug because it believed it answered a highly prevalent and increasing need.
There is further information about the drug on the IMB and EMEA websites at www.imb.ie and www.emea.europa.eu.



